Regulatory Affairs Europe, Associate Liaison

il y a 2 semaines


Bruxelles, Région de Bruxelles, Belgique MSD Temps plein
For our site in Brussels, we are looking for a Regulatory Affairs Europe, Associate Liaison

Primary Activities:

  • Provides administrative regulatory support during filing and review of new submissions, variations, in order to safeguard submissions according to EU requirements.
  • Plans and coordinates new submissions, variations, CHMP referrals, FUM. to ensure timely submission.
  • Drafts of module 1 components and organizing the gathering of the module 1 components.
  • Collaborates closely with Regulatory Operations to establish submission timelines and content of Module
  • Collaborates closely with Country RA Registration Managers in order to ensure timely submission.
  • For the centralized procedure, supervises and coordinates the translation process to ensure timely submission to EMA.
  • Provides other administrative support related to Marketing Authorization Applications to the Executive Director, Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist or Senior Scientist as needed.
  • Ensures updates to regulatory databases.
  • Keeps up to date with EU procedural requirements and legislation.
  • Participates as SME in relevant workstreams/projects as deemed appropriate by Regulatory Affairs Europe Senior Staff.
Education/skills

  • University degree (or similar such as A1 in Belgium), preferably in a science related to medicine, and at least four years of experience in the pharmaceutical industry with knowledge of the drug development and/or approval process.
  • Good organizational skills, proven ability to multitask, excellent written and verbal communication skills in English.
  • Can work across boundaries, demonstrates the ability to act as intermediary across boundaries.
  • Demonstrates the ability to evaluate new ideas and proposed methods for practicality and ease of implementation.
  • Demonstrates ability to coordinate tasks with others for timely completion and to avoid setbacks.

Search Firm Representatives Please Read Carefully

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:
R255967

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